Principal Scientist, SLS
Global Regulatory and Validation Consulting group, Pall Biotech
Sudhakar Nagaraj has been in Pharmaceutical industry for over 18 years and has held positions of increasing responsibility in Pharmaceutical QC/QA, R&D, Validations and Regulatory affairs. He joined Pall during 2006 in Scientific Laboratory Services (SLS) organization and has been involved in updating Pall’s technical support portfolios with rapidly evolving end-user and regulatory requirements, to streamline customer selection, adoption and successful regulatory approval of Pall technologies.
Currently, he is part of SLS Global Regulatory and Validation consulting team which is focused to provide streamlined technical guidance and scalable, customer-focused solutions to facilitate customer specification, qualification, validation and regulatory approval with Pall technologies. Examples of customer-focused solutions include application risk assessments for adoption of Pall technologies, development of improved Extractables and Leachables validation service, toxicology service, high risk filter validation (SOAR) service, customer-aligned change management model, online access to controlled filter integrity test values, standardized material compatibility information, Biotech material resins repository, BPOG & USP extractables datasets and QbD/QRM support packages.
Sudhakar Nagaraj is an active PDA India chapter member andrepresents Pall in Asia. He has completed post-graduation in Microbiology.